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Isotretinoin 5 mg daily for low-grade adult acne vulgaris - a placebo-controlled, randomized double-blind study
Background Despite acne persisting into adulthood in up to 50% of the population, very few therapeutic studies have been performed in this age group. Objectives To assess the efficacy of 5 mg/day isotretinoin in adult acne. Methods An investigator initiated, industry‐sponsored, randomized, double‐bl...
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| Published in: | Journal of the European Academy of Dermatology and Venereology 2014-06, Vol.28 (6), p.747-754 |
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| container_title | Journal of the European Academy of Dermatology and Venereology |
| container_volume | 28 |
| creator | Rademaker, M. Wishart, J.M. Birchall, N.M. |
| description | Background
Despite acne persisting into adulthood in up to 50% of the population, very few therapeutic studies have been performed in this age group.
Objectives
To assess the efficacy of 5 mg/day isotretinoin in adult acne.
Methods
An investigator initiated, industry‐sponsored, randomized, double‐blind, placebo‐controlled, parallel‐group clinical study of isotretinoin 5 mg/day in the treatment of low‐grade adult acne for 16 weeks followed by an open‐label phase of 16 weeks. Group 1 received 32 weeks of 5 mg isotretinoin/day; Group 2 first received 16 weeks of placebo, followed by 16 weeks open‐label 5 mg isotretinoin/day. Patients were followed for a further 10 weeks off treatment. The primary end‐point was the difference in acne lesion count and disability score after 16 weeks isotretinoin compared to placebo. Secondary end‐points included differences in these counts/scores after 32 weeks of isotretinoin compared to baseline, and after 10 weeks off treatment, compared to end of treatment (week 32).
Results
There were highly significant differences (P |
| doi_str_mv | 10.1111/jdv.12170 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1524174958</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1524174958</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3630-9bf478b2a427515b88f176a7a96ff83e7308f0ecb554e667868f3cee7a56c72c3</originalsourceid><addsrcrecordid>eNp1kMtuFDEQRS0EIkNgwQ8gL0HCid1uP3qJAnmgCBAKsLTcdnnk4G5P7O6E4Wv4Fr6Mhkmyoza1Ofeo6iL0nNEDtszhpb8-YA1T9AFasVZqwqnmD9GKdo0kXSe6PfSk1ktKKWNCP0Z7DZdMyY6v0Oas5qnAFMccRyx-_xrW2NuYtjjkglO-IetiPWDr5zRh60bA13Na2xIrJtjiTbIO-kxcHqeSUwL_Ghc7-jzEn-Cxz3OfgPQpjh7Xafbbp-hRsKnCs9u9j74cv7s4OiXnH0_Ojt6cE8clp6TrQ6t039i2UYKJXuuwXGyV7WQImoNaXgwUXC9EC1IqLXXgDkBZIZ1qHN9HL3feTclXM9TJDLE6SMmOkOdqmGhaptpO6AV9tUNdybUWCGZT4mDL1jBq_hZsloLNv4IX9sWtdu4H8PfkXaMLcLgDbmKC7f9N5v3br3dKskvEOsGP-4Qt341UXAnz7cOJOZaf9cWnpjOn_A9RTZUf</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1524174958</pqid></control><display><type>article</type><title>Isotretinoin 5 mg daily for low-grade adult acne vulgaris - a placebo-controlled, randomized double-blind study</title><source>Wiley-Blackwell Read & Publish Collection</source><creator>Rademaker, M. ; Wishart, J.M. ; Birchall, N.M.</creator><creatorcontrib>Rademaker, M. ; Wishart, J.M. ; Birchall, N.M.</creatorcontrib><description>Background
Despite acne persisting into adulthood in up to 50% of the population, very few therapeutic studies have been performed in this age group.
Objectives
To assess the efficacy of 5 mg/day isotretinoin in adult acne.
Methods
An investigator initiated, industry‐sponsored, randomized, double‐blind, placebo‐controlled, parallel‐group clinical study of isotretinoin 5 mg/day in the treatment of low‐grade adult acne for 16 weeks followed by an open‐label phase of 16 weeks. Group 1 received 32 weeks of 5 mg isotretinoin/day; Group 2 first received 16 weeks of placebo, followed by 16 weeks open‐label 5 mg isotretinoin/day. Patients were followed for a further 10 weeks off treatment. The primary end‐point was the difference in acne lesion count and disability score after 16 weeks isotretinoin compared to placebo. Secondary end‐points included differences in these counts/scores after 32 weeks of isotretinoin compared to baseline, and after 10 weeks off treatment, compared to end of treatment (week 32).
Results
There were highly significant differences (P < 0.0001) in acne lesion count, Dermatology Life Quality Index and self‐assessment after 16 weeks of isotretinoin, compared to placebo (both per protocol and intention to treat). Acne lesions fell significantly, within 4 weeks of 5 mg isotretinoin/day (Group 1) and continued to fall during 32 weeks of treatment [acne lesion count (mean ± SD): 11.3 ± 8.1 (baseline), 3.6 ± 5.5 (week 16), 1.3 ± 3.1 (week 32), P < 0.0001)]. There was a similar significant reduction in acne lesion count in Group 2, but only from week 20, 4 weeks after starting open‐label 5 mg isotretinoin. Adverse effects were minimal.
Conclusions
Isotretinoin 5 mg/day is effective in reducing the number of acne lesions, and improving patients dermatologic quality of life, with minimal adverse effects.</description><identifier>ISSN: 0926-9959</identifier><identifier>EISSN: 1468-3083</identifier><identifier>DOI: 10.1111/jdv.12170</identifier><identifier>PMID: 23617693</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Acne Vulgaris - drug therapy ; Adult ; Dermatologic Agents - administration & dosage ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Isotretinoin - administration & dosage ; Male ; Middle Aged ; Placebos ; Severity of Illness Index</subject><ispartof>Journal of the European Academy of Dermatology and Venereology, 2014-06, Vol.28 (6), p.747-754</ispartof><rights>2013 The Authors Journal of the European Academy of Dermatology and Venereology © 2013 European Academy of Dermatology and Venereology</rights><rights>2013 The Authors Journal of the European Academy of Dermatology and Venereology © 2013 European Academy of Dermatology and Venereology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3630-9bf478b2a427515b88f176a7a96ff83e7308f0ecb554e667868f3cee7a56c72c3</citedby><cites>FETCH-LOGICAL-c3630-9bf478b2a427515b88f176a7a96ff83e7308f0ecb554e667868f3cee7a56c72c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23617693$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rademaker, M.</creatorcontrib><creatorcontrib>Wishart, J.M.</creatorcontrib><creatorcontrib>Birchall, N.M.</creatorcontrib><title>Isotretinoin 5 mg daily for low-grade adult acne vulgaris - a placebo-controlled, randomized double-blind study</title><title>Journal of the European Academy of Dermatology and Venereology</title><addtitle>J Eur Acad Dermatol Venereol</addtitle><description>Background
Despite acne persisting into adulthood in up to 50% of the population, very few therapeutic studies have been performed in this age group.
Objectives
To assess the efficacy of 5 mg/day isotretinoin in adult acne.
Methods
An investigator initiated, industry‐sponsored, randomized, double‐blind, placebo‐controlled, parallel‐group clinical study of isotretinoin 5 mg/day in the treatment of low‐grade adult acne for 16 weeks followed by an open‐label phase of 16 weeks. Group 1 received 32 weeks of 5 mg isotretinoin/day; Group 2 first received 16 weeks of placebo, followed by 16 weeks open‐label 5 mg isotretinoin/day. Patients were followed for a further 10 weeks off treatment. The primary end‐point was the difference in acne lesion count and disability score after 16 weeks isotretinoin compared to placebo. Secondary end‐points included differences in these counts/scores after 32 weeks of isotretinoin compared to baseline, and after 10 weeks off treatment, compared to end of treatment (week 32).
Results
There were highly significant differences (P < 0.0001) in acne lesion count, Dermatology Life Quality Index and self‐assessment after 16 weeks of isotretinoin, compared to placebo (both per protocol and intention to treat). Acne lesions fell significantly, within 4 weeks of 5 mg isotretinoin/day (Group 1) and continued to fall during 32 weeks of treatment [acne lesion count (mean ± SD): 11.3 ± 8.1 (baseline), 3.6 ± 5.5 (week 16), 1.3 ± 3.1 (week 32), P < 0.0001)]. There was a similar significant reduction in acne lesion count in Group 2, but only from week 20, 4 weeks after starting open‐label 5 mg isotretinoin. Adverse effects were minimal.
Conclusions
Isotretinoin 5 mg/day is effective in reducing the number of acne lesions, and improving patients dermatologic quality of life, with minimal adverse effects.</description><subject>Acne Vulgaris - drug therapy</subject><subject>Adult</subject><subject>Dermatologic Agents - administration & dosage</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Humans</subject><subject>Isotretinoin - administration & dosage</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Severity of Illness Index</subject><issn>0926-9959</issn><issn>1468-3083</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNp1kMtuFDEQRS0EIkNgwQ8gL0HCid1uP3qJAnmgCBAKsLTcdnnk4G5P7O6E4Wv4Fr6Mhkmyoza1Ofeo6iL0nNEDtszhpb8-YA1T9AFasVZqwqnmD9GKdo0kXSe6PfSk1ktKKWNCP0Z7DZdMyY6v0Oas5qnAFMccRyx-_xrW2NuYtjjkglO-IetiPWDr5zRh60bA13Na2xIrJtjiTbIO-kxcHqeSUwL_Ghc7-jzEn-Cxz3OfgPQpjh7Xafbbp-hRsKnCs9u9j74cv7s4OiXnH0_Ojt6cE8clp6TrQ6t039i2UYKJXuuwXGyV7WQImoNaXgwUXC9EC1IqLXXgDkBZIZ1qHN9HL3feTclXM9TJDLE6SMmOkOdqmGhaptpO6AV9tUNdybUWCGZT4mDL1jBq_hZsloLNv4IX9sWtdu4H8PfkXaMLcLgDbmKC7f9N5v3br3dKskvEOsGP-4Qt341UXAnz7cOJOZaf9cWnpjOn_A9RTZUf</recordid><startdate>201406</startdate><enddate>201406</enddate><creator>Rademaker, M.</creator><creator>Wishart, J.M.</creator><creator>Birchall, N.M.</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201406</creationdate><title>Isotretinoin 5 mg daily for low-grade adult acne vulgaris - a placebo-controlled, randomized double-blind study</title><author>Rademaker, M. ; Wishart, J.M. ; Birchall, N.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3630-9bf478b2a427515b88f176a7a96ff83e7308f0ecb554e667868f3cee7a56c72c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Acne Vulgaris - drug therapy</topic><topic>Adult</topic><topic>Dermatologic Agents - administration & dosage</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Humans</topic><topic>Isotretinoin - administration & dosage</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Placebos</topic><topic>Severity of Illness Index</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rademaker, M.</creatorcontrib><creatorcontrib>Wishart, J.M.</creatorcontrib><creatorcontrib>Birchall, N.M.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the European Academy of Dermatology and Venereology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rademaker, M.</au><au>Wishart, J.M.</au><au>Birchall, N.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Isotretinoin 5 mg daily for low-grade adult acne vulgaris - a placebo-controlled, randomized double-blind study</atitle><jtitle>Journal of the European Academy of Dermatology and Venereology</jtitle><addtitle>J Eur Acad Dermatol Venereol</addtitle><date>2014-06</date><risdate>2014</risdate><volume>28</volume><issue>6</issue><spage>747</spage><epage>754</epage><pages>747-754</pages><issn>0926-9959</issn><eissn>1468-3083</eissn><abstract>Background
Despite acne persisting into adulthood in up to 50% of the population, very few therapeutic studies have been performed in this age group.
Objectives
To assess the efficacy of 5 mg/day isotretinoin in adult acne.
Methods
An investigator initiated, industry‐sponsored, randomized, double‐blind, placebo‐controlled, parallel‐group clinical study of isotretinoin 5 mg/day in the treatment of low‐grade adult acne for 16 weeks followed by an open‐label phase of 16 weeks. Group 1 received 32 weeks of 5 mg isotretinoin/day; Group 2 first received 16 weeks of placebo, followed by 16 weeks open‐label 5 mg isotretinoin/day. Patients were followed for a further 10 weeks off treatment. The primary end‐point was the difference in acne lesion count and disability score after 16 weeks isotretinoin compared to placebo. Secondary end‐points included differences in these counts/scores after 32 weeks of isotretinoin compared to baseline, and after 10 weeks off treatment, compared to end of treatment (week 32).
Results
There were highly significant differences (P < 0.0001) in acne lesion count, Dermatology Life Quality Index and self‐assessment after 16 weeks of isotretinoin, compared to placebo (both per protocol and intention to treat). Acne lesions fell significantly, within 4 weeks of 5 mg isotretinoin/day (Group 1) and continued to fall during 32 weeks of treatment [acne lesion count (mean ± SD): 11.3 ± 8.1 (baseline), 3.6 ± 5.5 (week 16), 1.3 ± 3.1 (week 32), P < 0.0001)]. There was a similar significant reduction in acne lesion count in Group 2, but only from week 20, 4 weeks after starting open‐label 5 mg isotretinoin. Adverse effects were minimal.
Conclusions
Isotretinoin 5 mg/day is effective in reducing the number of acne lesions, and improving patients dermatologic quality of life, with minimal adverse effects.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>23617693</pmid><doi>10.1111/jdv.12170</doi><tpages>8</tpages></addata></record> |
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| ispartof | Journal of the European Academy of Dermatology and Venereology, 2014-06, Vol.28 (6), p.747-754 |
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| language | eng |
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| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Acne Vulgaris - drug therapy Adult Dermatologic Agents - administration & dosage Double-Blind Method Drug Administration Schedule Female Humans Isotretinoin - administration & dosage Male Middle Aged Placebos Severity of Illness Index |
| title | Isotretinoin 5 mg daily for low-grade adult acne vulgaris - a placebo-controlled, randomized double-blind study |
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